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NCT Number: NCT07051109

Dual-chamber Patient-controlled Analgesia for Postoperative Recovery

Postoperative nausea and vomiting (PONV) are the most common complications that can occur after general anesthesia. Postoperative use of opioids and morbid obesity have been reported as risk factors of PONV. In this study, the investigators aimed to compare the degree of postoperative side effects and pain control when an intravenous patient-controlled analgesia combining fentanyl and ketorolac via a dual-chamber device was provided to participants undergoing laparoscopic sleeve gastrectomy.

Recruiting

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Key information

Age range

19 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyunggi-do, 13620, South Korea

Location status: Recruiting

Location contact

Insun Park, M.D./Ph.D.

CONTACT

[email protected]

823178777499

About this study

Morbidly obese patients undergoing laparoscopic sleeve gastrectomy experience a relatively high incidence of postoperative nausea and vomiting, but no effective treatment method has been established yet to prevent them. Through this study, the investigators can expect that if a dual-chamber patient-controlled analgesia device can provide effective analgesia while reducing the amount of opioid used, and thus reduce postoperative nausea and vomiting, it can have the effect of increasing the quality of recovery and satisfaction of participants who have undergone laparoscopic sleeve gastrectomy. Furthermore, this dual-chamber patient-controlled analgesia device can be applied to various surgeries and various patient groups who are at risk for postoperative nausea and vomiting, and it is expected that it can be adapted as one of the methods to prevent postoperative nausea and vomiting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult females aged 19 to 65 years
  • American Society of Anesthesiologists physical status (ASA class) 1 to 3
  • Patients scheduled for laparoscopic sleeve gastrectomy under general anesthesia
  • Patients requesting the use of IV-PCA after surgery

Exclusion criteria

  • Patients with hypersensitivity to the drugs used in this study (Ketorolac, Fentanyl)
  • Patients with alcohol or drug dependence, long-term use of opioids or analgesics
  • Patients with liver disease or renal failure
  • Patients with peptic ulcer, patients with gastrointestinal bleeding predisposition
  • Patients with suspected cerebrovascular hemorrhage, organic disorders of the head related to increased intracranial pressure
  • Patients with bronchial asthma or bronchospasm symptoms
  • Patients with severe respiratory depression
  • Nasal polyps, angioedema
  • Patients with or history of convulsive disease
  • Patients for whom the use of neuromuscular blocking agents is contraindicated

Treatment and study plan

multimodal analgesia via dual-chamber PCA

Device

combination of fentanyl and ketorolac through dual-chamber PCA

single regimen (only fentanyl)

Device

fentanyl only through dual-chamber PCA

Primary outcomes

  1. postoperative nausea and vomitting

    Time frame: postoperative 1 day

    The Quality of Recovery score 15

Study contacts

Contact information is provided by the study sponsor or research team.

Insun Park, M.D./Ph.D.

CONTACT

[email protected]

823178777499

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Comparison of Postoperative Recovery Between Dual-channel Pump for Intravenous Patient-controlled Analgesia(IV-PCA) and Conventional Single-channel Pump After Laparoscopic Sleeve Gastrectomy: a Prospective Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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